Treatment Protocol for the Compassionate Use of Domperidone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01696734
First received: September 27, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The goal of this clinical research study is to learn if domperidone can help to control chronic GI disorders. The safety of this drug will also be studied.

Domperidone is designed to stimulate contraction of the stomach to increase its ability to empty itself of the food.


Condition Intervention Phase
Gastrointestinal Diseases
Drug: Domperidone
Behavioral: Questionnaires
Other: Phone Calls
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Protocol for the Compassionate Use of Domperidone

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Symptom Control of Chronic Gastrointestinal Disorders [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Symptom control is defined as a 25% reduction in Gastroparesis Cardinal Symptom Index (GCSI) score compared to baseline. For discrete or categorical factors, descriptive statistics include tabulations of frequencies. For continuous data, summary statistics including n, mean, standard deviation, median, minimum, and maximum are computed. Bayesian 95% credible intervals for response rates and extreme toxicity rates are computed. Patient adverse events are tabulated by symptom, grade, and relationship to study drug. All outcome endpoints are examined by patient baseline characteristics such as gender, age, race/ethnicity, symptom manifestations, diagnosis subtype, and prior therapies.


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domperidone
10 mg 3 times a day at the onset of the study. The physician's decision to increase the dosage will be based on patient self-assessment of symptoms. The maximum dosage used in this study will be 80 mg per day (20 mg 4 times a day), and the minimum dosage will be 30 mg per day (10 mg 3 times a day). Questionnaire completion at baseline, 8 weeks after drug, 6 months, then every 6 months. At 2 weeks and 4 weeks(± 3 days) of treatment, the physician will contact the patient via telephone to assess whether or not a dosage increase is warranted.
Drug: Domperidone
Starting Dose: 10 mg by mouth 3 times a day.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks after drug, 6 months, then every 6 months.
Other Name: Surveys
Other: Phone Calls
At 2 weeks and 4 weeks(± 3 days) of treatment, the physician will contact the patient via telephone to assess whether or not a dosage increase is warranted.

Detailed Description:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take domperidone tablets with water about 30 minutes before a meal. You may be asked to take the tablets before bed.

During the study, the doctor may increase the amount of study drug you are taking.

You will need to record when you take the study drug in a study drug diary. This diary will be reviewed at clinic visits.

Study Procedures:

About 2 and 4 weeks after your first dose, the doctor will call you to ask you about symptoms you may be having.

About 8 weeks after your first dose, at Month 6, and then every 6 months after that:

  • You will have a physical exam, including measurement of your vital signs.
  • Your medical history will be recorded.
  • You will have an EKG.
  • You will be asked about any drugs you may be taking and side effects you may be having.
  • You will complete the 2 questionnaires about your GI symptoms.
  • Blood (about 3 tablespoons) will be drawn for routine tests.

Length of Study:

You may continue to take the study drug for as long as you are benefitting. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.

Follow-Up:

About 30 days after your last dose of study drug:

  • You will have a physical exam, including measurement of your vital signs.
  • Your medical history will be recorded.
  • You will have an EKG.
  • You will be asked about any drugs you may be taking and side effects you may be having.
  • Blood (about 3 tablespoons) will be drawn for routine tests.

If you are taken off study due to results of an EKG, you will be referred to the cardiology department for tests.

This is an investigational study. Domperidone is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 200 patients will be enrolled in this study. All will take part at MD Anderson.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with GI disorders who have failed standard therapy.
  2. Age 16 or older
  3. Symptoms or manifestations of: a) gastroparesis; b) refractory GERD including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia.
  4. Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms.
  5. Patient has signed the informed consent document agreeing to the use of the study drug, domperidone.
  6. WBC with differential greater than 3,000/ml; alkaline phosphatase less than 1.5 x upper limit of normal; ALT less than 2 x upper limit of normal; AST less than 2 x upper limit of normal; bilirubin less than or equal to 2 x upper limit of normal; BUN less than 2 x upper limit of normal; creatinine less than 1.5 x upper limit of normal; stable hemoglobin greater than or equal to 8.0 g/dl; potassium between range of 3.0 to 5.5.

Exclusion Criteria:

  1. Patients with the following cardiac diagnoses: Ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged QTc interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
  2. Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval)
  3. Patients who are receiving monoamine oxidase (MAO) inhibitors
  4. Patients with a history of or active liver failure
  5. Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5
  6. GI hemorrhage or obstruction experienced within the previous 6 weeks
  7. Presence of a prolactinoma (prolactin-releasing pituitary tumor)
  8. Pregnant or breast-feeding female (Women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
  9. Known allergy to domperidone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696734

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Mehnaz A. Shafi, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01696734     History of Changes
Other Study ID Numbers: 2012-0261, NCI-2012-02093
Study First Received: September 27, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal diseases
GI
Compassionate use
GI motility disorders
GI disorders
Gastroparesis
Gastroesophageal reflux disease
GERD
Chronic nausea and vomiting
Questionnaires
Surveys
Phone calls
Domperidone

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014